WHO Drug Information Vol. 20, No. 4, 2006 - World Health ...

More documents

Recommendations

Info

WHO Drug Information Vol 20, No. 4, 2006 Comparative studies are limited, but tolterodine has been included in a placebo-controlled trial of darifenacin. Unfortunately, a comparative analysis of the 15 mg dose of darifenacin was not carried out for all the outcomes. Darifenacin only achieved a statistical advantage over tolterodine for some outcomes if it was given at a daily dose of 30 mg. Darifenacin’s selective action does not appear to give it a large clinical advantage. Article drawn from: The Australian prescriber. Volume 29, Number 5, October 2006 at www.australianprescriber.com Reference 1. Haab F, Stewart L, Dwyer P. Darifenacin, an M3 selective receptor antagonist, is an effective and well-tolerated once daily treatment for overactive bladder. Eur Urol 2004;45:420-9. Tigecycline for serious infections Australia – Tigecycline (Tygacil®) vials containing 50 mg lyophilised powder for reconstitution have been approved for complicated skin and soft tissue infections and complicated intra-abdominal infections. Tigecycline is structurally related to the tetracycline class of antibiotics and is a derivative of minocycline. It has broad spectrum in vitro activity against Grampositive, Gram-negative and anaerobic organisms and also tetracycline-resistant bacteria. Coverage includes multiresistant bacteria such as methicillin-resistant Staphylococcus aureus (MRSA) and vancomycin-resistant enterococci. Tigecycline has poor activity against Pseudomonas species. Tigecycline is not absorbed from the gut so it must be administered by slow Safety and Efficacy Issues intravenous infusion. It is extensively distributed in the body and has a serum half-life of 40 hours. The tissue half-life is not known. Tigecycline is not extensively metabolised and so most of the drug is excreted unchanged in the urine and faeces. The safety and efficacy of tigecycline were evaluated for the treatment of skin and skin-structure infections from pooled data of two trials totalling 1116 hospitalized adults. Soft tissue infections, abscesses and infected ulcers were the most common type of infections in these patients. Cure rates for tigecycline and vancomycin/aztreonam were similar in trials. Both treatments were equally effective in patients with underlying comorbidities such as diabetes mellitus and peripheral vascular disease (1). The safety and efficacy of tigecycline were also evaluated for the treatment of complicated intra-abdominal infections, such as complicated appendicitis. Similar levels of drug efficacy were reflected in patients who were microbiologically evaluable (2). Although tigecycline has in vitro activity to multidrug resistant bacteria, there were limited data in these trials to support its use in patients with these infections. However, tigecycline was effective at eradicating MRSA in 25 out of 32 patients with complicated skin infections (1). The most common drug-related adverse events reported by tigecycline recipients were nausea and vomiting. Overall there were 30 deaths in the tigecycline groups and 18 deaths in the control groups. One death of a tigecycline recipient, after septic shock, was possibly related to the study drug. Tigecycline is not recommended for pregnant women or children. Tetracycline class effects, such as photosensitivity, may also occur in patients taking tigecycline. 259
Safety and Efficacy Issues Tigecycline provides an alternative antibiotic therapy for the treatment of serious infections in hospitalised adults. However, its effectiveness in treating multidrug resistant infections remains to be fully evaluated. Advice from an infectious disease specialist or bacteriologist should be sought before using tigecycline. Article drawn from The Australian prescriber. Volume 29, Number 5, October 2006 at www.australianprescriber.com 260 WHO Drug Information Vol 20, No. 4, 2006 References 1. Ellis-Grosse EJ, Babinchak T, Dartois N, Rose G, Loh E. The efficacy and safety of tigecycline in the treatment of skin and skin-structure infections: results of 2 doubleblind phase 3 comparison studies with vancomycin-aztreonam. Clin Infect Dis 2005;41:S341-53. 2. Babinchak T, Ellis-Grosse E, Dartois N, Rose GM, Loh E. The efficacy and safety of tigecycline for the treatment of complicated intra-abdominal infections: analysis of pooled clinical trial data. Clin Infect Dis 2005;41: S354-67. Spontaneous monitoring systems are useful in detecting signals of relatively rare, serious and unexpected adverse drug reactions. A signal is defined as "reported information on a possible causal relationship between an adverse event and a drug, the relationship being unknown or incompletely documented previously. Usually, more than a single report is required to generate a signal, depending upon the seriousness of the event and the quality of the information". All signals must be validated before any regulatory decision can be made.
Page 1 and 2: WHO DRUG INFORMATION V O L U M E 20
Page 3 and 4: World Health Organization 238 Annou
Page 5 and 6: Medicines for Tuberculosis • Acce
Page 7 and 8: Medicines for Tuberculosis pounds c
Page 9 and 10: Medicines for Tuberculosis InhA Inh
Page 11 and 12: 246 WHO Drug Information Vol 20, No
Page 13 and 14: Safety and Efficacy Issues 5. CDC.
Page 15 and 16: Safety and Efficacy Issues Referenc
Page 17 and 18: Safety and Efficacy Issues ADRAC ad
Page 19 and 20: Safety and Efficacy Issues 2. Clari
Page 21 and 22: Safety and Efficacy Issues Leflunom
Page 23: Safety and Efficacy Issues contribu
Page 27 and 28: Rational Use of Medicines The study
Page 29 and 30: Rational Use of Medicines fluticaso
Page 31 and 32: Topics of Current Interest Plan for
Page 33 and 34: Topics of Current Interest In order
Page 35 and 36: Topics of Current Interest from the
Page 37 and 38: Regulatory Action and News after se
Page 39 and 40: Regulatory Action and News The chan
Page 41 and 42: Recent Publications, Information an
Page 47 and 48: Proposed INN: List 96 WHO Drug Info
Page 75 and 76:
Proposed INN: List 96 WHO Drug Info
Page 77 and 78:
Page 79:
show all

WHO Drug Information Vol. 20, No. 4, 2006 - World Health ...

You also want an ePaper? Increase the reach of your titles

Delete template?

Save as template?